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U.S. Department of Health and Human Services

For Consumers

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Abbott Issues Correction for Certain Blood Glucose Meters

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Abbott, the manufacturer of medical products, has notified users of the following blood glucose meters (manufactured after Jan. 31, 2007) to check display screens to make sure that they are working properly:

  • Precision Xtra
  • Optium
  • ReliOn
  • Ultima
  • Rite Aid
  • Kroger

If the meters are dropped onto a hard surface, part of the display can be jarred or disconnected, making it difficult to read the lot number or date information. Dropping the meter also can cause the screen to appear blank, which might mean people cannot read their blood glucose results. Not being able to read the results may cause a significant risk for hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).

What Users Should Do
  • Stop using the meter immediately if you notice the display screen is not working properly.
  • Keep meters in the special wallet provided with the unit to offer additional protection for the meter.
  • Perform a meter display check, if the unit has been dropped onto a hard surface. (Instructions are detailed in the meter's "User Guide." If no problems are encountered, the meter is ready to use.)
  • Call Abbott at 1-877-844-4404 for assistance.

You can also report a problem with your glucose meter to MedWatch, the FDA's voluntary reporting program.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: September 13, 2007